510(k) K250850
K250850 is an FDA 510(k) premarket notification submitted by Nano-X Imaging , Ltd. for the device "Nanox.ARC X". The FDA issued a decision of Substantially Equivalent on April 16, 2025. The device falls under product code IZF (System, X-Ray, Tomographic), a Class II device regulated under 21 CFR 892.1740. Nano-X Imaging , Ltd. has at least 4 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- April 16, 2025
- Date Received
- March 20, 2025
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- System, X-Ray, Tomographic
- Device Class
- Class II
- Regulation Number
- 892.1740
- Review Panel
- RA
- Submission Type